Deter-X: Product Information

DETER-X- pramoxine hydrochloride ointment
EMS ACQUISITION CORP.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

PRAMOXINE HCL 1%

CCF08232014
(click image for full-size original)

DETER-X
pramoxine hcl ointment
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:59228-601
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 0.15 g in 15 g
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
DENATONIUM BENZOATE
DIGLYCERIN
GLYCERIN
DIACETYLATED MONOGLYCERIDES
MINERAL OIL
PROPYL GALLATE
PROPYLENE GLYCOL
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59228-601-15 15 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/02/2013
Labeler — EMS ACQUISITION CORP. (048602791)
Establishment
Name Address ID/FEI Operations
EMS ACQUISITION CORP. 048602791 manufacture
Establishment
Name Address ID/FEI Operations
AbbVie Inc. 078521674 api manufacture

Revised: 04/2022 EMS ACQUISITION CORP.

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